Federal Register notice: FDA determines that certain formulations of Baxter Pharmaceuticals Cytoxan (cyclophosphamide) for injection were not withdraw...
FDA clears a DePuy Synthes 510(k) for the TriLEAP Lower Extremity Anatomic Plating System, a modular, procedure-specific device for use in orthopedic ...
FDA warns Danvers, MA-based Abiomed about Quality System, Medical Device Reporting, and other violations in its marketing of Impella pumps and their C...
FDA issues Warning Letters to two online marketers promoting unapproved glucagon-like peptide-1 receptor agonists semaglutide and tirzepatide.
Three stakeholder organizations suggest changes to an FDA draft guidance on postmarketing approaches to obtain data on populations underrepresented in...
FDA releases the form FDA-483 with 14 observations from an inspection at the New Brunswick, NJ-based Spectrum Laboratory Products repacking/relabeling...
FDA publishes minor updates to two magnetic resonance guidances to harmonize them with the latest consensus standards.
FDA warns Miami, FL-based Dr. Antonio Blanco/Vista Health Research about conducting two clinical investigations in a way that did not follow the inves...
